Informations générales (source: ClinicalTrials.gov)

NCT02844049 En recrutement IDF
European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS Versus Best Medical Treatment (EQOLOC)
Interventional
  • Trouble obsessionnel compulsif
N/A
University Hospital, Grenoble (Voir sur ClinicalTrials)
septembre 2016
avril 2027
29 juin 2024
Obsessive-Compulsive Disorder (OCD) is among the most disabling psychiatric disorders as more than 40% of patients are resistant to the standard pharmacological and psychotherapy approaches and about 10% show severe disability and require institutionalization. These resistant patients may benefit from new surgical therapeutic approaches such as Deep Brain Stimulation (DBS) using high frequency stimulation of specific cerebral regions to modulate neural networks. Although promising, these results need nevertheless to be replicated and confirmed within a larger cohort of patients and considering a different main objective, instead of clinical improvement only. Indeed, despite a positive treatment response, adaptive functioning and quality of life may continue to be negatively impacted in OCD. Thus beyond symptom reduction, health-related quality of life (QoL) represents a more important objective of a treatment, as it includes both the individual's functional status and the individual's subjective perception of the impact of the illness on the patient's life. STN DBS induces significant clinical improvement, which may not be proportional to the QoL gain. Consequently, QoL appears to be a better outcome to target in the coming studies than clinical improvement alone. THe investigators thus propose a prospective study assessing the QoL changes of resistant OCD patients under STN DBS+BMT versus Best Medical Treatment (BMT) at 12 months, in order to assess the DBS induced gain in QoL in BMT-managed patients versus BMT alone.
 Voir le détail

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Henri Mondor-Albert Chenevier Complet Contact (sur clinicalTrials)
GHU PARIS PSY ET NEUROSCIENCES Philippe DOMENECH, MD PhD En recrutement IDF Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
APHP La Pitié Salpêtrière - Paris - France Bruno Millet, MD PhD En recrutement Contact (sur clinicalTrials)
Chu Nice - Hopital Pasteur - Nice - France Denys FONTAINE, MD En recrutement Contact (sur clinicalTrials)
University Hospital of Grenoble Michallon - Grenoble - France Mircea POLOSAN, MD PhD En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- OCD for > 5 years

- YBOCS> 25 and/or YBOCS sub-scale >15

- GAF< 45

- 3 or more documented SRI trials, including clomipramine (10-12 weeks at adequate
dose)

- SRI augmentation for > 4 weeks with at least one antipsychotic and with one of the
following: lithium, clonazepam

- Adequate trial of CBT (Exposure Therapy and Response Prevention) (intolerance or >15
sessions)

- Ability to provide informed consent


- Hoarding (if the only OCD symptom)

- OCD with poor insight (BABS score > 12)

- Lifetime diagnosis of psychosis or bipolar disorder;

- Substance abuse or dependence within the previous six months;

- Baseline Montgomery and Asberg (MADRS) suicidality item (item 10) score >2;

- Current DSM-5 personality disorder of Cluster A (e.g., paranoid or schizotypal
personality disorder) or B (e.g., borderline or antisocial personality disorder);

- Brain pathology, such as moderate or marked cerebral atrophy, stroke, tumor or
previous neurosurgical procedures (i.e. capsulotomy etc), history of cognitive
impairment and cognitive deterioration (Addenbrooke's Cognitive Examination ACE
score of < 80).

- Contra-indications to surgery, anaesthesia, or MRI

- compulsory hospitalization/ care; pregnant or nursing patients